NCT04580082

Brief Summary

The AMBR Study (ADHOC Mindfulness-Based Research Study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV over the age of 50. It is a substudy of the ADHOC study (ClinicalTrials.gov identifier NCT04311554).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

September 28, 2020

Last Update Submit

October 7, 2020

Conditions

HivLonelinessDepressionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    Change in loneliness using the 3-Item Loneliness Questionnaire (3IL). 3IL scores range from 3-9, with higher scores indicating greater loneliness.

    Baseline and follow-up, 25 days

Secondary Outcomes (2)

  • Anxiety

    Baseline and follow-up, 25 days

  • Depression

    Baseline and follow-up, 25 days

Study Arms (2)

Mindfulness lessons

EXPERIMENTAL

There are 14 lessons in total, each lasting approximately 20 minutes. Participants will be asked to listen to one lesson per day for 14 consecutive days, but to allow for possible missed days, they will have up to 25 days to complete as many of these 14 lessons as they can. The lessons will be delivered via the internet, and participants can use a variety of devices (e.g. smartphone, desktop computer, laptop computer, tablet) to access them. While the lessons cannot be downloaded, they are available for streaming anytime and anywhere there is an internet connection. Participants are welcome to revisit any lesson they have listened to previously, but are not allowed to "skip ahead" to other lessons until they have completed all preceding lessons. This is done because the lessons build on one another, which means that skipping lessons makes continued participation difficult. We will be able to track each participant's usage pattern and will analyze differences across users.

Behavioral: Mindfulness lessons

Delayed-start Mindfulness Lessons

OTHER

The control group will not receive the intervention until the intervention group has completed lesson listening. During this waiting period, they will receive periodic emails letting them know that their turn to listen to lessons is coming soon. Once available, the control group will have 25 days to listen to the 14 lessons.

Behavioral: Mindfulness lessons

Interventions

Mindfulness lessonsBEHAVIORAL

14 lessons on mindfulness, each lasting approximately 20 minutes.

Delayed-start Mindfulness LessonsMindfulness lessons

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ADHOC participant with a score of 4 or higher on the 3-item Loneliness Questionnaire from their ADHOC profile
  • Clinical diagnosis of HIV
  • Able to read and write in English
  • Able and willing to provide online informed consent and complete study activities online
  • Access to a smartphone or computer

You may not qualify if:

  • \- Acute medical problem(s) requiring immediate inpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mazonson & Santas Inc

Larkspur, California, 94939, United States

Location

Related Publications (1)

  • Berko J, Mazonson P, Short D, Karris M, Ehui L, Gutner CA, Spinelli F, Zolopa A. Waitlist-controlled trial of an online intervention to address mental health among older people living with HIV. Antivir Ther. 2023 Dec;28(6):13596535231216311. doi: 10.1177/13596535231216311.

    PMID: 38031911DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Peter Mazonson, MD, MBA

    Mazonson & Santas Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 8, 2020

Study Start

May 21, 2020

Primary Completion

September 4, 2020

Study Completion

September 28, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)